I contribute to clinical research with expertise and empathy. And I do it
Senior Manager, Regulatory Affairs
Primary Location: India, Remote Job ID R0000043228 Category Regulatory / Consulting Date Posted 07/24/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
A Senior Manager within R&A provides leadership and direction to consultants, senior consultants and managers, actively managing employee performance and development. A Senior Manager acts as a role model and provides a broad range of consulting services and may be responsible for a specific function/technical area.
Key Responsibilities
- Extensive experience in Regulatory Affairs, including expertise in EU Clinical Trials Regulation (EU CTR) and experience leading and developing teams.
- Act as the Subject Matter Expert (SME) for the EU Clinical Trials Regulation (EU CTR), providing strategic regulatory guidance and ensuring compliant implementation.
- Drive capability building within the team through coaching, mentoring, training, and knowledge-sharing initiatives.
- Contribute to organizational EU CTR-related projects, process improvements, and strategic initiatives.
- Support the development, review, and maintenance of functional Standard Operating Procedures (SOPs).
- Provide support during regulatory audits and inspections.
- Deliver regulatory consultancy and client-focused guidance, fostering strong stakeholder partnerships.
- Lead and manage a team, ensuring performance, development, and operational excellence.
Skills and Competencies
- Strong expertise in EU Clinical Trials Regulation (EU CTR) and associated regulatory requirements.
- Ability to interpret regulatory intelligence, assess impact, and translate requirements into practical processes and implementation plans.
- Solid understanding of regulatory operations, workflows, and compliance standards.
- Excellent stakeholder management and communication skills, with experience collaborating across global teams and clients.
- Strong analytical, problem-solving, decision-making, and risk mitigation capabilities in a dynamic environment.
- Demonstrated ability to work collaboratively and influence cross-functional teams in a consultative manner.
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